IDMPC: Improving Depression Management

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05050227
Collaborator
(none)
74
Enrollment
1
Location
2
Arms
43.9
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Depression is disabling and affects one in five Veterans. VA's Primary Care-Mental health Integration (PC-MHI) enables specialists to support medication treatment in primary care, but timely and sufficient access to psychotherapy is unattainable despite Veteran preference for psychotherapy. This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting and pilot testing PC-MHI collaborative care models to improve uptake of computerized cognitive behavioral therapy (cCBT).

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: cCBT Enhanced Collaborative Care
  • Behavioral: Usual Care
N/A

Detailed Description

Background: VA's Primary Care-Mental Health Integration (PC-MHI) is rooted in evidence-based collaborative care models, where care managers, mental health specialists, and primary care providers jointly treat depression in primary care. While PC-MHI enabled specialists to support medication treatment in primary care, timely and sufficient access to psychotherapy is unattainable. Alternative therapy modalities are needed.

Significance/Impact: Depression is disabling and affects one in five Veterans. Psychotherapy is preferred by Veterans, but fraught with multilevel barriers (e.g., staff availability, patient travel to clinic, limited clinic hours). Without enhancing existing PC-MHI models to enable better primary care patient access to effective psychotherapies, Veteran engagement in depression treatment is unlikely to improve.

Innovation: This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting PC-MHI collaborative care models to improve uptake of computerized cognitive behavioral therapy (cCBT). cCBT is accessible 24/7 via the internet and has effectively treated depression in more than 30 trials. With modest specialist support, it is non-inferior to face-to-face psychotherapy. PC-MHI can facilitate Veteran uptake of cCBT, using an evidence-based collaborative care model to provide the follow-up care management and mental health specialist back-up that characterizes the most effective cCBT trials.

Specific Aims/Methodology: To pilot test the feasibility, acceptability, and potential effects of cCBT-enhanced collaborative care on Veterans' depression symptoms and related outcomes in VA Greater Los Aneles Healthcare System. A pilot randomized controlled trial (RCT) will be conducted to examine feasibility, acceptability, and potential effects on depression, patient activation, and health-related quality of life in VA primary care patients with depression receiving either (1) cCBT-enhanced collaborative care (n=37) or (2) usual care (n=37) in West Los Angeles VA, from baseline to 3-months (post-intervention).

Next Steps/Implementation: Adapting PC-MHI's collaborative care model to incorporate cCBT can improve access to psychotherapy and engage the ~400,000 untreated Veterans with depression who prefer psychotherapy, especially OIF/OEF/OND Veterans seeking care that is convenient.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Improving Depression Management in Primary Care (CDA 19-108)
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Sep 29, 2023
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: cCBT Enhanced Collaborative Care

Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a depression care manager in addition to the usual care provided.

Behavioral: cCBT Enhanced Collaborative Care
Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session "homework"), and monitor mental health symptoms for each participant.

Active Comparator: Usual Care

Participants in the usual care arm will receive the usual care provided as described below.

Behavioral: Usual Care
Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.

Outcome Measures

Primary Outcome Measures

  1. Patient Health Questionnaire (PHQ-9) [3-months]

    The Patient Health Questionnaire (PHQ-9) is a scale commonly used to measure and categorize depression symptoms. It is already administered as part of routine primary care at our study site.

Secondary Outcome Measures

  1. PROMIS Global Health [3-months]

    The 10-item PROMIS Global Health assesses health-related quality of life and is summarized into "Physical Health" (e.g., physical functioning, pain, fatigue) and "Mental Health" (e.g., emotional problems, social functioning).

  2. Generalized Anxiety Disorder (GAD-7) [3-months]

    The 7-item Generalized Anxiety Disorder (GAD-7) is among the most commonly used and best validated anxiety measures in primary care settings.

  3. Patient Activation Measure (PAM) [3-months]

    The 13-item Patient Activation Measure (PAM) will be used to assess an individual's knowledge, skill, and confidence for self-management.

  4. PTSD Checklist for DSM-5 (PCL-5) [3-months]

    The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-reported measure that will be used to assesses PTSD symptoms and symptom change.

  5. Behavioral Activation for Depression Scale (BADS-SF) [3-months]

    The 9-item Behavioral Activation for Depression Scale (BADS-SF) will also be used to examine behavioral activation as an intermediary to depression symptomatology outcomes.

Other Outcome Measures

  1. Treatment Engagement [3-months]

    Treatment engagement will be conceptualized as the number of cCBT sessions completed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Have access to computer (mobile or desktop), internet, telephone, and email

  • Able to read English text on a computer screen

  • Score 10 or higher on the PHQ-9

Exclusion Criteria:
  • Have moderate-high suicide risk (e.g., suicide flag) or active suicidality

  • Have other serious mental illness (e.g. bipolar disorder, psychosis)

  • Have medical disorder that would prevent/interfere with participation (e.g. dementia/cognitive impairment, terminal illness)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los AngelesCaliforniaUnited States90073

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Lucinda B Leung, MD MPH PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT05050227
Other Study ID Numbers:
  • CDX 21-004
  • IK2HX002867
First Posted:
Sep 20, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021